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Transcatheter aortic-valve implantation (TAVI) is an established treatment option in patients with severe symptomatic aortic stenosis. Intermediate and long-term follow up data of these patients is limited. Data was taken from a large all-comer single center prospective registry (2008 to 2019). The primary end point was all-cause mortality. The secondary endpoints were long-term valve hemodynamic performance; paravalvular leak (PVL) at 5-year follow-up. We also report on temporal trends in this cohort. Our cohort included 998 patients with a mean age of 82.3 ± 7.2 years and 52.2% females. TAVI was performed via the transfemoral, trans-apical, subclavian and other access routes in 93.9%, 3.6%, 2.5%, and 0.6% of patients, respectively. A self-expandable device was used in 69.4% of cases, balloon expandable device in 28.1% and in 2.5% other devices. The cumulative risk for all-cause mortality at 5 years was 43.4% (95% CI 39.1 to 47.7). The immediate and long-term valve gradients were low and maintained. On durability analysis at 5 years, severe structural valve deterioration was present in 1.6% of cases. At 5-year follow-up, PVL was moderate in 3.3% and no patients has severe PVL. On temporal trends analysis, we found that the procedural aspects of TAVI improved over time with lower rates of significant PVL and significantly lower procedural mortality. In conclusion, TAVI patients have a favorable long-term outcome, with excellent valve hemodynamic parameters and good clinical outcomes. Over time and with increasing experience, procedural and patient outcomes have improved., Competing Interests: Disclosures The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Advanced chronic kidney disease (CKD) is an independent predictor of mortality in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to identify predictors of 1-year mortality in patients after TAVI stratified by the presence or absence of advanced CKD (defined as estimated glomerular filtration rate ≤30 ml/min/1.73 m 2 or permanent renal replacement therapy). Patients (n = 1204) from 10 centers in Europe, Japan, and Israel were included: 464 with and 740 without advanced CKD. Advanced CKD was associated with a 2-fold increase in the adjusted risk of 1-year all-cause death (p <0.001), and a 1.9-fold increase in cardiovascular death (p = 0.016). Interaction-term analysis was used to identify and compare independent predictors of 1-year mortality in both groups. Impaired left ventricular ejection fraction and poor functional class were predictive of death in the advanced CKD group (odds ratio [OR] 2.27, p = 0.002 and OR 3.87, p = 0.003, respectively) but not in patients without advanced CKD (p for interaction = 0.035 and 0.039, respectively), whereas bleeding was a predictor of mortality in the nonadvanced CKD group (OR 3.2, p = 0.005) but not in advanced CKD (p for interaction = 0.006). Atrial fibrillation was associated with a 2.2-fold increase (p = 0.032) in the risk of cardiovascular death in the advanced CKD group but not in the absence of advanced CKD (p for interaction = 0.022). In conclusion, the coexistence of advanced CKD and either reduced left ventricular ejection fraction or poor functional class has an incremental effect on the risk of death after TAVI. In contrast, bleeding had a greater effect on risk of death in patients without advanced CKD., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis in patients at high or prohibitive surgical risk. Nevertheless, long-term clinical and echocardiographic data are still lacking. We carried out an analysis of 560 consecutive patients who underwent TAVI at our institution from 2008 to 2016 to evaluate temporal changes in TAVI characteristics, predictors of 1-year and long-term outcomes, and to compare the performance of the early- and new-generation valve systems. With time, we have adopted lower risk threshold for patient selection and have been using conscious sedation and transfemoral access preferentially (p <0.001 for all). The incidence of greater than mild PVL decreased from 16% to 7.6%, p = 0.029. Within 5 years, 47% of the patients died, the majority (78%) due to noncardiac causes. Independent predictors of 1-year death included periprocedural aspects (i.e., vascular complications, stroke, and PVL), whereas death occurring later than 1 year was solely related to baseline co-morbidities. Transvalvular gradients and residual regurgitation remained nonclinically significant for up to 5 years of follow-up. New-generation valves were associated with less PVL compared with propensity score-matched early-generation valves (p <0.001). In conclusion, TAVI utilization at our institution has progressed to include lower risk patients with transfemoral access becoming applicable in the great majority. Poor long-term survival is attributable to population factors rather than to procedural factors. Intermediate- and long-term hemodynamics are excellent. PVL has diminished significantly with the new-generation valves. Efforts to improve long- and short-term outcomes remain a therapeutic challenge., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Patients with advanced chronic renal dysfunction were excluded from randomized trials of transcatheter aortic valve replacement (TAVR). The potential impact of chronic renal disease on TAVR prognosis is not fully understood. We aim to evaluate outcomes within a large cohort of patients who underwent TAVR distinguished by renal function. Baseline characteristics, procedural data, and clinical follow-up findings were collected from 10 high-volume TAVR centers in Europe, Israel, and Japan. Data were analyzed according to renal function. Patients (n = 1,204) were divided into 4 groups according to pre-TAVR-estimated glomerular filtration rate (eGFR): group I (eGFR >60), n = 288 (female 45%), group II (eGFR 31 to 60), n = 452 (female 61%), group III (eGFR ≤30), n = 398 (female 61%), and group IV (dialysis), n = 66 (female 31%). Mean Society of Thoracic Surgeons score was higher in patients with lower preprocedural eGFR. All-cause mortality at 1 year was higher in patients with lower eGFR (9.0%, 12.1%, 24.3%, and 24.2% for group I, II, III, and IV, respectively, p <0.001). Multivariate analysis demonstrated that eGFR ≤30, but not eGFR 31 to 60, was associated with increased risk of death (odds ratio 3), bleeding (odds ratio 5.2), and device implantation failure (hazard ratio 2.28). For each 10 ml/min decrease in eGFR, there was an associated relative increase in the risk of death (35%; p <0.001), cardiovascular death (14%; p = 0.018), major bleeding 35% (p <0.001), and transcatheter valve failure (16%; p = 0.007). Renal dysfunction was not associated with stroke or need for pacemaker implantation. In conclusion, among patients who underwent TAVR, baseline renal dysfunction is an important independent predictor of morbidity and mortality., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) is an established technique for the treatment of severe symptomatic aortic stenosis. Data on long-term TAVI outcomes, both hemodynamic and clinical, in real-world practice settings are limited. We aim to explore the long-term clinical results in patients with severe symptomatic aortic stenosis using multiple catheter-based options: 360 TAVI-treated patients were followed up for ≤5 years. The Medtronic CoreValve was used in 71% and the Edwards SAPIEN in 26%. The primary end point was all-cause mortality during follow-up. Outcomes were assessed based on the Valve Academic Research Consortium 2 criteria. The mean ± SD patient age was 82.1 ± 6.9 years (56.4% women). The Society of Thoracic Surgeons score was 7.5 ± 4.7. The clinical efficacy end point and time-related valve safety at 3 years was 50% and 81.7%, respectively. The calculated 3- and 5-year survival rates were 71.6% and 56.4%, respectively. Five-year follow-up data were obtained for 54 patients alive; 96.2% of alive patients were in the New York Heart Association class I and II, 4 years after TAVI. No gender differences in all-cause mortality rates were observed (p = 0.58). In multivariate analysis, hospitalization 6 months previous to TAVI (hazard ratio [HR] 1.92, 95% confidence interval [CI] 1.17 to 3.15, p = 0.01), frailty (HR 1.89, 95% CI 1.11 to 3.2, p = 0.02), acute kidney injury (HR 1.93, 95% CI 1.03 to 3.61, p = 0.04), and moderate or more paravalvular aortic regurgitation after TAVI (HR 4.26, 95% CI 2.54 to 7.15, p <0.001) were independent predictors for all-cause mortality. In conclusion, long-term outcomes of TAVI are encouraging. Prevention and early identification of paravalvular leak and acute renal failure after the procedure would improve short- and long-term outcomes., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The aim of this study was to identify predictors of 30-day and midterm mortality after transcatheter aortic valve implantation (TAVI) by means of a systemic review. TAVI was demonstrated to be safe and efficacious in patients with severe aortic stenosis. An accurate estimation of procedural risk of these patients represents an actual challenge. The PubMed and Cochrane Collaboration databases were systematically searched for studies reporting on the incidence and independent predictors of 30-day and midterm mortality. Adverse events were pooled with random effect, whereas independent predictors are reported as odds ratios (ORs) with 95% confidence intervals (CIs). A total of 25 studies with 8,874 patients were included (median age 82.5 ± 1.5 years, 54.6% women). At 30 days, 7.5% of patients (n = 663) died. At midterm follow-up (median 365 days, interquartile range 267 to 365 days), the cumulative mortality rate was 21.6% (n = 1,917). Acute kidney injury (AKI) stage ≥2 (OR 18.0, 95% CI 6.3 to 52), preprocedural hospitalization for heart failure (OR 9.4, 95% CI 2.6 to 35), periprocedural acute myocardial infarction (OR 8.5, 95% CI 2.6 to 33.5), and increased pro-brain natriuretic peptide (pro-BNP) levels (OR 5.4, 95% CI 1.7 to 16.5) were the most important independent predictors of 30-day mortality. Increased pro-BNP levels (OR 11, 95% CI 1.5 to 81), AKI stage 3 (OR 6.8, 95% CI 2.6 to 15.7), left ventricular ejection fraction <30% (OR 6.7, 95% CI 3.5 to 12.7), and periprocedural acute myocardial infarction (OR 6.5, 95% CI 2.3 to 18.1) represented the predictors of midterm mortality. In conclusion, in this large meta-analysis of patients undergoing TAVI, we found that high pro-BNP levels and postprocedural AKI were the strongest independent predictors of both 30-day and 1-year mortality. These findings may contribute to a better understanding of the risk assessment process of patients undergoing TAVI., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) is an emerging technique for the treatment of severe symptomatic aortic stenosis. Little has been reported about the use of different devices and multiple catheter-based options and anesthetic techniques in the same institution. We report the long-term clinical experience in treating patients with severe symptomatic aortic stenosis using TAVI. We analyzed the outcomes of 153 TAVI-treated patients who were followed for ≤2 years. All patients were at very high risk of surgical valve replacement. The Medtronic-CoreValve device was used in 59.5% and the Edwards-SAPIEN device in 40.5% of the patients. The primary end point was death from any cause during follow-up. The mean ± SD patient age was 81.1 ± 6 years, and 62% of the patients were women. The procedural success rate was 97.4%. At 30 days of follow-up, the all-cause mortality was 3.9%. Two-year follow-up data were obtained for 108 patients, with 85.5% survival of treated patients. The 30-day stroke rate was 3.9%. No significant differences in mortality were found when angioplasty was performed before or during TAVI compared with TAVI alone. Multivariate analysis showed that increased baseline creatinine (hazard ratio 1.55, 95% confidence interval 1.01 to 2.42, p = 0.049) and increased logistic European System for Cardiac Operative Risk Evaluation score (hazard ratio 1.03, 95% confidence interval 1.01 to 1.06, p = 0.048) predicted all-cause mortality. In conclusion, the clinical outcome of TAVI is favorable. The use of both procedural devices and multiple techniques in the same institution is feasible and potentially desirable., (Copyright © 2013 Elsevier Inc. All rights reserved.)

High on-treatment platelet reactivity (HTPR) despite clopidogrel therapy is associated with adverse cardiac events after acute myocardial infarction (AMI). Most studies to date have assessed clopidogrel response at a single time point before or after percutaneous coronary intervention (PCI). It is unclear, however, whether the HTPR phenotype is stable over time. Therefore, we aimed to examine response to clopidogrel in patients with AMI treated with PCI over a 6-month period. Patients (n = 57) with AMI treated with PCI were assessed for response to clopidogrel at 3 time points: in hospital, 30 days, and 6 months after index hospitalization. Response to clopidogrel was determined by the VerifyNow P2Y12 assay (reported as P2Y12 response units) and multiple electrode aggregometry (MEA; reported as aggregation units). HTPR was defined as ≥235 P2Y12 response units or ≥47 aggregation units. Patients' mean age was 54.5 ± 10.9 years, 91% were men, 19% had diabetes, and 74% were admitted with ST-segment elevation MI. HTPR based on MEA was observed in 22.8% of patients in hospital, 26.3% at 30 days, and 17.5% at 6 months (p = NS). HTPR based on the VerifyNow assay was observed in 38.6% of patients in hospital, 28.1% at 30 days, and 33.3% at 6 months (p = NS). Individual HTPR phenotypic assignment at baseline was stable in 73.7% (based on MEA) and 70.2% (based on VerifyNow) of patients at 6-month follow-up. In conclusion, this is the first study evaluating the stability of clopidogrel response over time after AMI. Rates of HTPR to clopidogrel therapy appear to be relatively stable up to 6 months after AMI., (Copyright © 2012 Elsevier Inc. All rights reserved.)